NCT00940433

Brief Summary

This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1.8 years

First QC Date

July 15, 2009

Last Update Submit

January 14, 2010

Conditions

Inguinal Hernia

Keywords

Minimally invasiveInguinal herniaPro-peritoneal repair

Outcome Measures

Primary Outcomes (1)

  • patient ability to resume domestic activity independently

    daily reporting by the patient

Secondary Outcomes (1)

  • time of the patient to return to work

    reported by the patient

Study Arms (4)

open properitoneal

ACTIVE COMPARATOR

patients undergoing open properitoneal hernia repair

Procedure: open properitoneal hernia repair

Lechtenstien repair

ACTIVE COMPARATOR

Patients undergoing Lechtestien hernia repair

Procedure: Lechtestien hernia repair

Laparoscopic transperitoneal repair

ACTIVE COMPARATOR

Patients undergoing TAPP repair

Procedure: Laparoscopic transperitoneal approach

Lap totally extraperitoneal approach

ACTIVE COMPARATOR

Patients undergoing TEP approach

Procedure: Laparoscopic totally extraperitoneal approach

Interventions

open properitoneal hernia repairPROCEDURE

suprapubic retro-inguinal approach

Also known as: extraperitoneal repair
open properitoneal
Lechtestien hernia repairPROCEDURE

onlay mesh repair

Also known as: tension free repair
Lechtenstien repair
Laparoscopic transperitoneal approachPROCEDURE

intraperitoneal insufflation followed by re-exiting to the hernia site

Also known as: TAPP
Laparoscopic transperitoneal repair
Laparoscopic totally extraperitoneal approachPROCEDURE

avoiding the peritoneum altogether

Also known as: TEP
Lap totally extraperitoneal approach

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult male primary inguinal hernia

You may not qualify if:

  • recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main University hospital

Alexandria, Alexandria Governorate, 261112, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetra-4-amidinophenoxypropanetetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Yasser Hamza, A professor

    University of Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 16, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

EG(1)